By Counterforce Health Team in Lumizyme (alglucosidase alfa) —

How to Get Lumizyme (alglucosidase alfa) Covered by UnitedHealthcare in New Jersey: Appeals Guide & Decision Tree

Quick Answer: Do You Qualify for Lumizyme Coverage?

Yes, if you have confirmed Pompe disease and meet UnitedHealthcare's criteria. The fastest path: Your metabolic specialist submits prior authorization through the UHC Provider Portal with GAA enzyme test results, genetic confirmation, and baseline functional assessments. If denied, request a peer-to-peer review immediately, then escalate to New Jersey's IHCAP external review program through Maximus Federal Services. Start today: Gather your enzyme test results and contact your prescriber to initiate the prior authorization process.

Table of Contents

How to Use This Decision Tree

This guide helps you navigate UnitedHealthcare's prior authorization process for Lumizyme (alglucosidase alfa) in New Jersey. Work through each section based on where you are in the process. If you're unsure about your diagnosis or testing, start with the eligibility triage. If you've already been denied, jump to the appeals section.

Important: This applies to fully-insured UnitedHealthcare plans and NJ FamilyCare. Self-funded employer plans follow different rules and aren't eligible for New Jersey's external review program.

Eligibility Triage: Do You Qualify?

✅ Likely Eligible if you have:

  • Confirmed Pompe disease diagnosis through GAA enzyme testing (blood, skin, or muscle biopsy)
  • Genetic confirmation showing two disease-causing GAA gene variants
  • Specialist prescriber: metabolic specialist, endocrinologist, or biochemical geneticist
  • Baseline assessments completed (pulmonary function tests, 6-minute walk test for ages 12+)
  • Documentation of medical necessity from your specialist

⚠️ Possibly Eligible if you have:

  • Clinical suspicion of Pompe disease but incomplete testing
  • Low GAA enzyme activity but no genetic confirmation yet
  • Primary care prescriber (may need specialist consultation)
  • Some baseline testing but missing required assessments

❌ Not Yet Eligible if you have:

  • No enzyme testing or normal GAA activity levels
  • Alternative diagnoses not ruled out
  • No specialist involvement in diagnosis or treatment planning

If "Likely Eligible": Your Action Plan

Document Checklist

Gather these items before your prescriber submits the prior authorization:

Required Documentation:

  • GAA enzyme assay results showing deficiency
  • Genetic testing confirming GAA mutations
  • Specialist consultation notes
  • Current weight for dosing calculation (20 mg/kg every 2 weeks)
  • Baseline pulmonary function tests (ages 12+)
  • 6-minute walk test results (ages 12+)
  • Medical necessity letter addressing diagnosis and treatment goals

Submission Process

  1. Your specialist submits via UHC Provider Portal using Specialty Pharmacy Transactions
  2. Timeline: Standard decisions within 15 business days; expedited within 72 hours if medically urgent
  3. Follow-up: Track status through provider portal or call OptumRx at 888-397-8129
Tip: Request expedited review if you have progressive symptoms or respiratory decline. Include documentation of clinical urgency in the submission.

If "Possibly Eligible": Tests You Need

Essential Diagnostic Tests

GAA Enzyme Testing:

  • Dried blood spot, skin fibroblast, or muscle biopsy
  • Must show absent or reduced acid alpha-glucosidase activity
  • Contact: Invitae or other certified labs (10-21 day turnaround)

Genetic Confirmation:

  • GAA gene sequencing to identify disease-causing mutations
  • Required for late-onset Pompe disease
  • Two pathogenic variants needed for diagnosis

Functional Assessments (Ages 12+):

  • Pulmonary function testing (PFT) with forced vital capacity (FVC)
  • 6-minute walk test (6MWT) for baseline measurement
  • Muscle strength evaluation

Timeline to Re-apply

  • Complete testing: 4-6 weeks for genetic results
  • Specialist consultation: Schedule within 2-3 weeks
  • Resubmit PA: Once all documentation is complete

If "Not Yet Eligible": Alternative Options

Discuss with Your Provider

Other Pompe Treatments:

  • Nexviazyme (avalglucosidase alfa) - newer enzyme replacement therapy
  • Pombiliti/Opfolda combination for late-onset Pompe disease
  • Supportive care through multidisciplinary Pompe centers

Exception Request Strategy:

  • Document why standard alternatives aren't appropriate
  • Include literature supporting Lumizyme for your specific case
  • Request medical director review if initial criteria aren't met

Preparing for Future Authorization

  • Complete comprehensive Pompe disease workup
  • Establish care with metabolic specialist
  • Document disease progression and functional decline
  • Gather family history and genetic counseling records

If Denied: New Jersey Appeal Process

Step 1: Internal Appeals (UnitedHealthcare)

First-Level Appeal:

  • Submit within 180 days of denial notice
  • Use UHC Provider Portal for electronic submission
  • Include additional clinical evidence addressing denial reasons

Peer-to-Peer Review:

  • Request clinical discussion with UHC medical director
  • Your specialist can directly advocate for medical necessity
  • Often resolves denials before formal written appeal

Step 2: New Jersey External Review (IHCAP)

If internal appeals fail, New Jersey's Independent Health Care Appeals Program provides independent review:

Eligibility:

  • Completed UHC's internal appeal process
  • Denial based on medical necessity or similar criteria
  • Fully-insured NJ plan or NJ FamilyCare (not self-funded)

How to File:

  • Contact: Maximus Federal Services at 1-888-393-1062 (ext. 50998)
  • Online: njihcap.maximus.com
  • Deadline: Within 4 months (120 days) of final internal denial
  • Cost: Free to patients and providers

Timeline:

  • Preliminary review: 5 business days
  • Full decision: 45 days for standard appeals
  • Expedited: Within 72 hours for urgent cases
Note: Maximus decisions are binding on UnitedHealthcare. Success rates for well-documented appeals can reach 50% or higher.

Coverage Requirements at a Glance

Requirement Details Documentation Needed
Prior Authorization Required for all requests Complete PA form via provider portal
Diagnosis Confirmed Pompe disease GAA enzyme + genetic testing
Prescriber Metabolic specialist or equivalent Consultation notes, credentials
Dosing 20 mg/kg IV every 2 weeks Current weight, dosing calculation
Baseline Testing PFT, 6MWT (ages 12+) Test results, dates performed
Reauthorization Every 12 months Evidence of clinical benefit

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
"Diagnosis not confirmed" Submit complete testing GAA enzyme assay + genetic results
"Not prescribed by specialist" Add specialist consultation Metabolic specialist evaluation
"Missing baseline assessments" Complete required testing PFT, 6MWT results for ages 12+
"Not medically necessary" Strengthen clinical case Disease progression, functional decline
"Alternative therapies not tried" Document contraindications Prior therapy failures, intolerances

Source: UnitedHealthcare Prior Authorization Guidelines

From Our Advocates: We've seen well-documented Lumizyme appeals succeed when families work closely with their metabolic specialists to address every denial criterion point-by-point. The key is showing clear disease progression and why enzyme replacement therapy is essential for this patient's specific clinical picture. While outcomes vary, thorough preparation significantly improves approval chances.

Counterforce Health: Turning Denials into Approvals

Counterforce Health specializes in helping patients and clinicians navigate complex specialty drug appeals like Lumizyme. Our platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-backed appeals tailored to each payer's requirements. For Pompe disease cases, we help gather the right clinical citations, format medical necessity letters, and ensure all procedural requirements are met for both internal appeals and external reviews.

FAQ: Lumizyme Coverage in New Jersey

Q: How long does UnitedHealthcare prior authorization take? A: Standard requests: 15 business days. Expedited requests (for urgent medical needs): 72 hours. Track status through the UHC Provider Portal.

Q: What if Lumizyme is non-formulary on my plan? A: Request a formulary exception with documentation that preferred alternatives are inappropriate, contraindicated, or have failed.

Q: Can I request an expedited appeal in New Jersey? A: Yes, both UnitedHealthcare internal appeals and IHCAP external reviews offer expedited processes for urgent medical situations.

Q: Does step therapy apply to Lumizyme? A: UnitedHealthcare may require trying other Pompe treatments first, but exceptions are available if alternatives are contraindicated or have failed.

Q: What's the cost of Lumizyme without insurance? A: Approximately $993 per 50mg vial (Sanofi wholesale price). Monthly costs can exceed $20,000 depending on patient weight and dosing.

Q: Are there financial assistance programs? A: Yes, Sanofi offers patient assistance programs. Contact Lumizyme.com for eligibility and application information.

Q: What happens if IHCAP overturns the denial? A: UnitedHealthcare must comply with the decision and provide coverage. The external review decision is legally binding on the insurer.

When to Contact New Jersey Regulators

If you experience procedural violations or bad faith denials, contact:

NJ Department of Banking and Insurance

Sources & Further Reading

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider about your specific medical condition and treatment options. Coverage decisions depend on individual plan benefits and medical circumstances. For assistance with complex appeals, consider working with specialists like Counterforce Health who understand payer-specific requirements and can help optimize your submission strategy.

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